12 Questions to Ask Any Stem Cell Clinic Before You Book

Before you commit to any regenerative medicine procedure, you deserve clear answers to specific questions about cell sourcing, regulatory status, physician oversight, published evidence, and what to expect after you pay. The right clinic will welcome these questions; vague or defensive responses are themselves a red flag.

Stem cell therapy has moved from academic research labs into clinical practice over the past fifteen years, but the field remains investigational for most conditions. Individual responses vary widely, and no therapy has certain outcomes. What follows is a framework for asking the questions that separate evidence-based, physician-supervised care from clinics making promises the published literature cannot support.

What questions to ask a stem cell clinic should I prioritize?

Start with the twelve questions below, organized into six categories: cell origin and processing, regulatory compliance, who performs the procedure, what the published data actually show, cost transparency, and follow-up protocols. A clinic willing to answer all twelve in writing before you book is a clinic operating with nothing to hide.

The first two questions address the biological starting material. Where do the cells come from—your own tissue, donor tissue, or a laboratory culture? How are they isolated, expanded, or concentrated, and does that processing change their regulatory classification? These questions matter because the FDA draws a bright line between minimally manipulated autologous cells (your own cells, used during the same procedure) and cells that are cultured, expanded, or significantly altered. The latter require pre-market approval as a drug, which very few stem cell products currently hold.

The next cluster of questions asks who is medically accountable. Is a physician performing the procedure, or supervising a nurse practitioner or physician assistant? What are that physician's board certifications, and do they have specific training in regenerative medicine? Dr. Charles Pereyra, MD, a board-certified emergency medicine physician, screens every candidate at Springs Rejuvenation to assess whether the investigational approaches offered align with the individual's medical history and goals.

Questions five through eight focus on evidence. What peer-reviewed studies support this therapy for your specific condition? Were those studies randomized and controlled, or were they case series and observational reports? How many patients were enrolled, and what were the measured outcomes? A clinic that cites only its own unpublished data, patient testimonials, or white papers from cell-processing companies is not offering evidence in the scientific sense.

The final four questions address practical transparency: total cost, what happens if the therapy does not produce the anticipated response, how outcomes are tracked, and what adverse events have been reported. Any clinic hesitant to discuss these points in plain language before you pay is asking you to accept risk without informed consent.

Where do the cells come from, and how are they processed?

The biological origin of the cells determines both the regulatory pathway and the scientific rationale. Autologous therapies harvest cells from your own bone marrow, adipose (fat) tissue, or blood during the same visit, then isolate and concentrate them before reinjection. Because the cells are minimally manipulated and returned to your body on the same day, the FDA classifies these procedures under Section 361 of the Public Health Service Act—meaning they are regulated as human tissue, not as drugs, and do not require pre-market approval.

Allogeneic therapies, by contrast, use donor cells from umbilical cord tissue, placental membranes, or bone marrow. If these cells are more than minimally manipulated—cultured in a lab, expanded to increase their numbers, or genetically modified—they fall under Section 351 and require an Investigational New Drug application and rigorous clinical trials before the FDA will approve them for marketing. Most allogeneic stem cell products currently advertised in the United States have not completed that approval process.

Ask the clinic to explain, in writing, whether the cells are autologous or allogeneic, how they are processed, and under which FDA regulatory pathway the therapy falls. If the answer is vague, or if the clinic claims its product is "FDA-registered" without clarifying that registration does not mean approval, that is a signal to keep asking.

Early research on a population of cells called Muse (multi-lineage differentiating stress-enduring) cells offers one example of the scientific questions still under investigation. Kuroda, Dezawa, and colleagues (2010) first characterized Muse cells as a rare subset of pluripotent-like cells found in adult bone marrow and other tissues. Wakao, Dezawa, and others (2011) demonstrated that these cells could differentiate into multiple tissue types under laboratory conditions. Later, Yamada and colleagues (2018) showed that when Muse cells are administered intravenously in preclinical models, the S1P–S1PR2 signaling axis guides them preferentially to sites of tissue injury.

In a first-in-human Japanese safety study (Noda 2020), intravenous Muse cells were assessed in a small cohort, and the trial met its primary safety endpoint. A subsequent randomized, double-blind Japanese trial (Niizuma 2023) evaluated intravenous Muse cells in a different acute condition; the study was published in a peer-reviewed journal, but the primary efficacy endpoint showed modest improvement, and responses were not uniform across all participants. These studies illustrate both the promise of allogeneic cell therapies and the early stage of the evidence base. No Muse cell product is FDA-approved for any indication in the United States, and outcomes in individual patients remain investigational.

Is the therapy FDA-registered, and what does that actually mean?

The term "FDA-registered" is often used in marketing, but it does not mean FDA-approved. Any facility that manufactures human cells or tissue must register with the FDA and list its products, but that registration is a compliance step, not an endorsement of safety or efficacy. It means the FDA knows the facility exists and what it is processing—nothing more.

Section 361 therapies, which involve minimal manipulation of a patient's own cells during a single procedure, are exempt from pre-market approval but must still meet manufacturing standards and infection-control requirements. Section 351 therapies, which involve donor cells or more extensive processing, are regulated as biological drugs and require the full clinical-trial pathway—Phase I safety studies, Phase II dose-finding, and Phase III randomized controlled trials—before the FDA will approve them for a specific indication.

Ask the clinic whether the therapy you are considering is offered under Section 361 or Section 351, and if it is the latter, whether the FDA has granted an Investigational New Drug exemption. If the clinic cannot answer that question clearly, or if it conflates registration with approval, that is a reason to pause.

Who will perform my procedure, and what are their credentials?

Regenerative medicine procedures involve needle aspiration of bone marrow or adipose tissue, centrifugation to concentrate cells, and targeted injection into joints, soft tissue, or intravenous infusion. These are medical procedures that carry risks—infection, bleeding, adverse reactions to local anesthesia, and rare but serious complications such as embolism if cells are not processed correctly. The person performing the procedure should be a licensed physician with verifiable training in the specific techniques involved.

Some clinics delegate the procedure to nurse practitioners or physician assistants working under a physician's nominal supervision. While these providers are highly trained within their scope of practice, regenerative medicine is a field where physician-level anatomic knowledge, experience managing acute complications, and accountability for outcomes matter. Ask who will be in the room, who will hold the syringe, and what that person's board certifications are.

Dr. Charles Pereyra conducts a comprehensive medical evaluation for every candidate, reviewing past therapies, imaging studies, and relevant lab work to determine whether an investigational regenerative approach is appropriate. That physician-supervised candidacy screening is one reason patients no longer need to travel overseas to access Muse cell therapy and other investigational protocols—physician-led clinics in the United States now offer these approaches under appropriate regulatory and ethical oversight.

What published research supports this approach?

Published research is the foundation of evidence-based medicine, but not all publications carry equal weight. A single case report describing one patient's positive response is hypothesis-generating, not proof of efficacy. A randomized, double-blind, placebo-controlled trial with a pre-registered protocol and independent oversight is the gold standard. Ask the clinic to cite specific peer-reviewed studies, and then look them up yourself to see what they actually concluded.

For example, Hare and colleagues (2009) published a randomized trial in the Journal of the American College of Cardiology assessing the safety of intravenous allogeneic mesenchymal stem cells in a small cohort. The study met its safety endpoints and suggested that intravenous MSC administration was well-tolerated, but it was not designed to establish efficacy for any specific outcome. Bartolucci and others (2017) conducted the RIMECARD trial, in which patients with chronic advanced conditions received umbilical-cord-derived MSCs and showed improvements in certain measured parameters, including an average increase of approximately seven points in ejection fraction. These findings are encouraging but represent early-stage clinical research, and individual responses varied.

The published literature is not uniformly positive. Some studies fail to meet their primary endpoints, others show no difference between the active therapy and placebo, and nearly all acknowledge that much larger trials are needed to establish which patients are most likely to respond. A clinic that presents only its own unpublished case series, or that claims every patient responds, is not accurately representing the state of the science.

How much does it cost, and what's included?

Regenerative therapies are rarely covered by insurance, so you will be paying out of pocket. Total costs vary widely depending on the cell source, the volume of cells administered, the number of injection sites, and the clinic's overhead. Autologous bone-marrow-derived therapies for a single joint might range from $3,000 to $7,000; intravenous allogeneic therapies can exceed $15,000 per infusion, and some protocols involve multiple infusions over several months.

Ask for an itemized estimate in writing that includes the initial consultation, imaging if required, the cell harvest or procurement, laboratory processing, the injection procedure, and any follow-up visits. Clarify whether physical therapy, follow-up imaging, or additional injections are part of the package or billed separately. A transparent clinic will provide this breakdown before you commit.

Also ask what happens if the therapy does not produce the response you were hoping for. Will the clinic offer a partial refund, a second procedure at reduced cost, or simply move on to the next patient? The answer to that question tells you whether the clinic stands behind its work or views you as a one-time transaction.

Beware of pressure tactics—limited-time discounts, claims that "this is your last chance to avoid surgery," or suggestions that waiting a few weeks will make you ineligible. A legitimate clinic will give you time to review the information, consult with your primary care physician or orthopedic surgeon, and make an informed decision without a countdown clock.

What follow-up and outcome tracking does the clinic provide?

Regenerative therapies do not produce overnight results. Depending on the condition, the cell type, and the individual's biology, it can take weeks to months before any change in pain, function, or mobility becomes apparent. Some patients report improvement that plateaus after three to six months; others notice gradual gains over a year or more; still others see no change at all. Ask the clinic how it tracks outcomes and whether it participates in any registry or long-term follow-up study.

A clinic committed to advancing the field will ask you to return for standardized assessments—pain scales, range-of-motion measurements, functional questionnaires, follow-up imaging—at defined intervals. That data, when aggregated across many patients, helps researchers understand which protocols work, for whom, and under what circumstances. If the clinic has no formal follow-up protocol and does not ask you to report your outcomes, that suggests it is not interested in learning from its own experience.

Also ask whether the clinic reports adverse events to the FDA's MedWatch system. Any medical procedure carries risk, and responsible practitioners track and report complications. A clinic that claims it has never had an adverse event either has supported very few patients or is not being forthright.

Two lists can help clarify candidacy. Patients who are often a good fit for investigational regenerative approaches include those with early-to-moderate degenerative joint changes who have tried physical therapy and anti-inflammatory measures without sufficient relief, those who wish to delay or avoid joint replacement, and those whose general health and tissue quality support healing. Patients for whom a conversation with the physician is especially important include those with advanced bone-on-bone arthritis (where mechanical joint damage may exceed what cell-based therapies can address), those with active infections or uncontrolled inflammatory conditions, those on immunosuppressive medications, and those with limited mobility or comorbidities that complicate the procedure.

Neither list is absolute. Every case is individual, and physician evaluation is essential. The point of these categories is to help you enter the consultation with realistic expectations.

What are the biggest red flags to watch for?

Promises of certain outcomes are the first red flag. No therapy—regenerative or otherwise—has certain outcomes, and any clinic that promises you will avoid surgery, regain full function, or experience a specific degree of improvement is either uninformed or dishonest. Published trials consistently show that responses vary, and investigational therapies by definition lack the long-term data to support sweeping promises. If a clinic's marketing materials read like testimonials rather than patient education, take that seriously.

Should I expect to see results immediately after the procedure?

No. Most patients experience some soreness or swelling at the injection site for the first few days, similar to what you might feel after a corticosteroid injection or a minor injury. Some clinics advise avoiding anti-inflammatory medications during the first week, on the theory that inflammation is part of the healing signal, though the evidence for that recommendation is limited. Meaningful changes in pain or function, if they occur, typically emerge over a period of weeks to months, not days.

Can I combine stem cell therapy with other approaches?

In many cases, yes. Physical therapy, weight management, activity modification, and joint-support supplements are not mutually exclusive with regenerative therapies. Some clinics incorporate platelet-rich plasma alongside stem cell injections, though the evidence for additive benefit is still under investigation. Gentile and Garcovich (2019) published a systematic review of PRP for androgenetic alopecia, noting that small studies suggested benefit but that larger controlled trials were needed. Shin and others (2015) assessed adipose-derived stem cell conditioned media for hair regeneration in a small cohort and reported encouraging preliminary findings, though again the study size and lack of long-term follow-up limit generalizability. The key is to discuss any combination approach with your physician and understand the rationale and evidence for each component.

What should I do if the clinic refuses to answer any of these questions?

Walk away. A clinic that will not disclose its cell source, its regulatory status, the credentials of the person performing the procedure, or the published evidence supporting its protocol is not operating with the transparency that patients deserve. Medical care—especially elective, out-of-pocket, investigational care—requires informed consent, and informed consent requires information. If a clinic deflects your questions, changes the subject, or tells you that "all of that is advanced," you are being asked to trust without verification. That is not a reasonable request.

At Springs Rejuvenation, stem cell and exosome therapies are used together as part of a personalized regenerative protocol.